Dataset Information

Oil-based or saline contrast for sono-hysterosalpingography in infertile women: a pilot randomized controlled double blind trial.

ABSTRACT:

Objective

To determine the feasibility, safety, and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography in women with infertility.

Design

Randomized Controlled Double Blind Clinical Trial.

Setting

Academic health center.

Interventions

Tubal flushing with oil-based contrast medium (Lipiodol UF) versus saline.

Main outcome measures

Ongoing pregnancy rate, pain, quality of life, and thyroid function.

Results

Forty-eight patients (24 in each group) were analyzed. The groups were well-matched at baseline. Ongoing pregnancy was noted in 17% (4/24) of the oil-contrast group versus 37% (9/24) in the saline group. Saline group patients more frequently initiated infertility therapy in the six-month follow-up period (saline, 67% vs. oil, 33%), and no serious adverse events in either group. There were no differences in pain from the procedure between groups. There were no differences in thyroid function tests postprocedure between groups, but within the oil-contrast group, there was a slight increase in thyroid-stimulating hormone (post vs. preratio of geometric means: 1.18; 95% confidence interval [CI], 1.02-1.38) and decrease in Free T4 (postdifference vs. predifference in means: 0.08 ng/dL; 95% CI, -0.14 to -0.01). Immediately after the test, the physicians correctly guessed 79% of oil and 71% of saline randomization assignments, whereas patients correctly guessed 63% of oil and 38% of saline.

Conclusions

This pilot study demonstrates the safety and feasibility of giving an oil-based contrast medium during ultrasound-imaged hysterosalpingography. Pregnancies were seen after oil-based administration, and this contrast is associated with minor thyroid function impairment.

SUBMITTER: Legro RS

PROVIDER: S-EPMC10028425 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Oil-based or saline contrast for sono-hysterosalpingography in infertile women: a pilot randomized controlled double blind trial.

Legro Richard S RS Stetter Christy M CM Kunselman Allen R AR Geisler William M WM Dodson William C WC Estes Stephanie J SJ

F&S reports 20221115 1

<h4>Objective</h4>To determine the feasibility, safety, and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography in women with infertility.<h4>Design</h4>Randomized Controlled Double Blind Clinical Trial.<h4>Setting</h4>Academic health center.<h4>Interventions</h4>Tubal flushing with oil-based contrast medium (Lipiodol UF) versus saline.<h4>Main outcome measures</h4>Ongoing pregnancy rate, pain, quality of life, and thyroid function.<h4>Results ...[more]

PMID: 36959970

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Project description:BackgroundIn women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography (HSG) increases ongoing pregnancy and subsequent live birth rates when compared to tubal flushing with water-based contrast. It is currently unclear whether an HSG with oil-based contrast also results in more ongoing pregnancies and live births in women of advanced age, women with ovulation disorders, and women with potential tubal pathology when compared to an HSG with water-based contrast.MethodsWe plan an international, multicentre, open-label, randomized controlled trial (RCT) studying three groups of infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39 years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history. Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprolactinemia or untreated hyper- or hypothyroidism, and women with a partner with severe male infertility. After informed consent, women will be randomly allocated to the intervention, tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor. The primary endpoint will be ongoing pregnancy leading to live birth with conception within six months after randomization. Secondary outcomes are other pregnancy outcomes, used fertility treatments, adverse events and cost-effectiveness. Based on the expected ongoing pregnancy rate of 17% in the control group and 27% in the intervention group, the sample size will be 930 women (465 per group). Study inclusion is expected to be complete in four years.DiscussionThis multicentre RCT will establish whether, for women of advanced age, women with ovulatory disease, and women who have a high risk for tubal pathology, there is a fertility enhancing effect of tubal flushing with oil-based contrast during HSG and whether the use of this contrast medium is cost-effective. Trial Registration The study was prospectively registered in the Netherlands Trial Register on August 1st 2019 as 'H2Oil2' (reference number NL7925, https://www.trialregister.nl/trial/7925 ).

Project description:BACKGROUND:Four-dimensional hysterosalpingo-contrast sonography (4D-HyCoSy) is the preferred way for evaluating fallopian tubal patency and it associated with higher rate of spontaneous conception. However, Few studies have evaluated the influencing factors of spontaneous conception in 4D-HyCoSy and suggested ways to choose treatment options after 4D-HyCoSy. The study was to evaluate the correlation between spontaneous conception outcome and the patients' clinical characteristics as well as tubal patency in infertile women to provide reference on ways to manage the patient after 4D-HyCoSy. METHODS:This was a retrospective study and analysis of two hundred and eighty three (283) infertile patients who underwent a 4D-HyCoSy between December 2014 and October 2017 in our center. Eligible patients were those whose partners semen parameters were normal when based on World Health Organization (WHO) criteria, and had spontaneous conception without clinical interventions after 4D-HyCoSy. RESULT(S):One hundred and sixteen patients (40.9%) conceived spontaneously and the mean conception time was (8.8?±?0.3) months. Within a year after 4D-HyCoSy, the spontaneous conception rate was highest in type VI(62.5%), followed by type IV (46.2%), type III (44.4%), type V (39.4%), type II (33.9%) and type I (14.8%). With Cox regression analysis, two factors associated with spontaneous conception outcome appeared to increase spontaneous conception rate: patients with type IV or type VI tubes and duration of infertility less than 2?years. The age, type of infertility, multiparas, history of pelvic surgery, history of uterine cavity operation, uterine fibromyomata and polycystic ovary were unrelated to spontaneous conception outcome after 4D-HyCoSy. CONCLUSION(S):This study showed that some infertile women could succeed in spontaneous conception after 4D-HyCoSy. Hence, We recommend the usage of 4D-HyCoSy as first line for tubal patency test and infertile patients should be advised to accept 4D-HyCoSy examination as soon as possible. Expectant treatment of about 8-9?months is reported to be feasible for infertile women whose 4D-HyCoSy findings showed one tube patency or poor patency. Alternatively, an immediate clinical intervention is recommended for those with bilateral obstructed tubes .

Project description:BackgroundHome parenteral nutrition (HPN) can be associated with increased liver enzymes, catheter-related bloodstream infections (CRBSI), and hospitalizations. Mixed oil (MO) versus soybean oil (SO) lipid emulsion reduces risks in hospitalized patients, but there are no randomized double-blinded controlled trials in HPN. Therefore, the primary objective was to test the study's feasibility such as recruitment and retention in the HPN population and the secondary objective was to assess changes in liver enzymes between MO and SO as well as other clinical and biochemical outcomes.MethodsThis 13-month prospective double-blind crossover randomized pilot trial took place in Toronto, Canada. Participants were HPN patients who were a part of the HPN program at Toronto General Hospital. We recruited patients from the HPN program. HPN patients receiving SO were randomized to either MO or SO, and the study duration was 6 months in each arm (MO or SO) with a 1-month washout period resuming SO. As this is a crossover trial design, the patient is his/her own control. The main outcome measures were descriptions of study feasibility, namely the study recruitment and retention. We also collected biochemical parameters, CRSBI, hospitalization rate, antibiotic use, and mortality. Demographic, nutritional, clinical, and laboratory data were collected at baseline, 3 and 6 months of each arm. The primary analysis population was defined as the per-protocol population who completed the trial including all lipid measurements.ResultsA total of 65 HPN patients were assessed, and 60 met the inclusion criteria for the study. Thirty-five percent (21/60) were randomized using a computer-generated random number sequence generator: 10 participants were randomized to receive SO first while 11 were randomized to receive MO first. At 13 months, 3/10 who received SO first completed the study, whereas 9/11 who received MO first completed the study. This did not meet our a priori criteria for success in recruitment and retention. Between types of lipid emulsions, there were no significant differences in changes in liver enzymes or biochemical and clinical outcomes, despite significant changes in plasma free fatty acid composition reflecting MO or SO.ConclusionsOverall, this pilot trial demonstrated that the use of a prospective double-blind, crossover, randomized trial design was not feasible to conduct in the HPN population because of difficulties in recruiting and retaining patients. In addition, there was no significant impact of MO versus SO lipid emulsion on liver enzymes or most parameters. The lack of significance may be attributed to low sample size from low recruitment and high drop-out rate, short study duration (6 months/arm), and complex care. In a future definitive trial, a multicenter study of longer duration and a larger sample size is recommended, and drop-outs may be reduced by using a parallel study design.Trial registrationClinicalTrials.gov, NCT02796833. Registered on 13 June 2016-retrospectively registered.

Project description:IntroductionIn recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG.Methods and analysisThis study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups.Ethics and disseminationThis protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.Trial registration numberChiCTR2000031612.

Project description:BackgroundThe efficacy of ethiodized poppyseed oil in hysterosalpingography (HSG) image quality and fertility enhancement has been revealed, but whether this HSG modality has similar effects in the Chinese population is still unclear.MethodsBetween July 18, 2017, and December 29, 2019, this multicentric, randomized, two-arm, clinical trial was performed involving 15 medical centers. Infertile women meeting HSG indications were randomly assigned to an oil group and a water group. The coprimary outcome included HSG image quality during HSG and fertility-enhancing effects of HSG. This study was registered on ClinicalTrials.gov (NCT03370575).FindingsA total of 1026 subjects were randomly assigned to an oil group (N = 508) and a water group (N = 518). HSG image quality revealed that the oil group had outstanding visualization (all P < 0.001); total image quality scores for uterus opacification or uterine outline (2.9 ± 0.4 vs. 2.7 ± 0.5), fallopian tube outline (2.3 ± 0.8 vs. 1.7 ± 0.7), fimbrial rugae (1.7 ± 1.0 vs. 1.3 ± 0.8), fallopian tube spillage (2.1 ± 0.9 vs. 1.6 ± 0.8), peritoneal distribution (2.6 ± 0.9 vs. 2.1 ± 1.0) and diagnostic quality (11.6 ± 3.4 vs. 9.5 ± 3.1) (all P < 0.001) were higher in the oil group than in the water group. Regarding fertility-enhancing evaluation, the oil group showed an increased cumulative on-going pregnancy rate, on-going pregnancy within 6 months (29.1% vs. 20.1%), clinical pregnancy (39.5% vs. 29.1%) and live birth ≥ 24 weeks of gestation (36.1% vs. 27.7%) but a shorter time to pregnancy than the water group (all P < 0.01). Concerning adverse events, the oil group showed a lower occurrence rate of abdominal pain and vaginal bleeding after HSG (both P < 0.01).InterpretationEthiodized poppyseed oil-based contrast is superior to water-based contrast during HSG in terms of image quality improvement and fertility enhancement. This study indicates the priority of the application of ethiodized poppyseed oil-based contrast during the HSG procedure in infertile patients.FundingNo funding was received.

Dataset Information

Oil-based or saline contrast for sono-hysterosalpingography in infertile women: a pilot randomized controlled double blind trial.

Objective

Design

Setting

Interventions

Main outcome measures

Results

Conclusions

Publications

Oil-based or saline contrast for sono-hysterosalpingography in infertile women: a pilot randomized controlled double blind trial.

Similar Datasets

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